EC clears AbbVie's oral hepatitis C regimen

Viekirax and Exviera offer competition to Gilead’s Sovaldi

AbbVie is celebrating the approval of its all-oral hepatitis C treatment in Europe, just a few weeks after the blockbuster-in-waiting was registered in the US.

The approval of Viekirax (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir), which follows a recommendation from the European Medicines Agency (EMA), will allow AbbVie to take its fight with rival Gilead Sciences in the hepatitis C virus (HCV) market onto a second front.

The interferon-free regimen - which is based on three directly-acting antivirals and a boosting agent, was approved by the FDA as Viekira Pak in December as the first major competition to Gilead's Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) franchise, and has also been given a green light in Canada.

Gilead has already made billions of dollars in revenues from its all-oral HCV therapies, which have largely done away with the need for hard-to-tolerate - and less effective - interferon alfa infections. AbbVie's regimen is expected to be its closest rival in the evolving HCV market.

Viekirax and Exviera have been approved in the EU for use - with or without ribavirin - in patients with genotype 1 chronic HCV, including those with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients. Viekirax has also been approved for use with ribavirin in genotype 4 HCV.

AbbVie chief executive Richard Gonzalez said that Viekirax and Exviera are a "new and effective treatment to cure this serious disease", adding that the company was "committed to working with local governments and healthcare systems to support broad access" to them.

Despite Gilead's lead in the US market AbbVie has already made in-roads into its market share, thanks to a reduced price versus Harvoni that encouraged health insurer Express Scripts to include only Viekira in its formulary at the end of last year.

Since then, it has emerged that Gilead has offered a deal to rival insurer Humana that has secured exclusivity for Harvoni in its formulary in return for an undisclosed discount. Other insurers are likely to be considering this type of approach, although doctors have complained that this type of horse-trading impacts on their treatment decisions.

The move is significant as Gilead has staunchly resisted any discounting for Sovaldi in high-income countries, on the grounds that its drugs are not much more expensive than interferon/ribavirin therapy and a fraction of the cost of a liver transplant.